Important Safety Information CREON may increase the chance of having a rare bowel disorder called fibrosing colonopathy
52) Because of the possible risk of fibrosing colonopathy
with very high doses of enzyme replacement, a ceiling of 75 000 IU of lipase per meal has been recommended by some.
Solvay will also be required to conduct a 10-year observational study to evaluate the incidence of fibrosing colonopathy
in cystic fibrosis patients treated with Creon, and to evaluate the risk of transmission of selected porcine viruses in treated patients, according to the FDA approval letter.
Pancreatic enzyme supplementation in cystic fibrosis patients before and after fibrosing colonopathy.
High dose pancreatic enzyme supplements and fibrosing colonopathy in children with cystic fibrosis.
This case suggests that multiple etiologic factors, and not simply exposure to pancreatic enzymes, may result in fibrosing colonopathy in adults with cystic fibrosis.
A less well-known complication is fibrosing colonopathy (FCP), characterized histologically by submucosal fibrosis, and clinically by obstructive symptoms.
The incidence of fibrosing colonopathy
, associated with high doses of pancreatic enzymes and/or the use of high strength preparations in the early 1990s (7-9), caused many centres treating CF to review the practices of their patients and collaborate to produce national guidelines (4,10,11).
CREON may increase the chance of having a serious bowel disorder called fibrosing colonopathy
PANCREAZE may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy
that may require surgery.
Warnings and precautions include fibrosing colonopathy
, a rare, serious adverse reaction that has been described in association with high-dose use of pancreatic enzyme replacement therapy in the treatment of cystic fibrosis patients.
As part of the REMS, a Medication Guide with important dosing and safety information applicable to this class of products, including CREON(R), is provided for patients and caregivers, with an emphasis on understanding the risk of fibrosing colonopathy
as well as the importance of not over- or under-dosing.